Status:
COMPLETED
Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Lead Sponsor:
RenJi Hospital
Conditions:
Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell ...
Detailed Description
This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell ...
Eligibility Criteria
Inclusion
- Non-metastatic biopsy-proven clear cell renal cell carcinoma (T2-T3N0-1M0)
- Schedule to undergo either partial or radical nephrectomy as part of treatment plan
- ECOG performance status of 0 or 1
- Adequate organ and marrow function defined by study-specified laboratory tests
- Agree to comply with scheduled visits, treatment plans, lab tests and other study procedures
- Do not have any other cancers in the 5 yr preceding diagnosis of their renal cancer
Exclusion
- Patients who have received other systems for anti-tumor treatment
- Patients who have previously received targeted or immunotherapy
- Need for urgent or emergent nephrectomy to relieve symptoms
- Current use of immunosuppressive agents
- Pregnant or breastfeeding women
- History of autoimmune disease or syndrome
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04118855
Start Date
March 1 2020
End Date
March 31 2023
Last Update
April 4 2023
Active Locations (1)
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1
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China, 200127